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Ongoing FDAEvent 99712 (24 days ago)

Sterling Pharmaceutical Services Lubricant Eye Drops and Ointments

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% lacks assurance of sterility.

Moderate risk

Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Sterling Pharmaceutical Services LLC of Dupo, Illinois, recalled products due to a lack of assurance of sterility, as stated by the FDA. The recall began August 20, 2026, and was added to the FDA's Enforcement Report on September 21, 2026.

The products include Walgreens Lubricant Eye Drops, AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Reliable-1 Laboratories products, Major LubriFresh P.M. Nighttime Ointment, and TRP The Relief Products Gentle Eyes Lubricant Eye Drops, distributed nationwide.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:

  1. Check the FDA or company notice for instructions specific to this product.
  2. Ask your pharmacist or doctor whether your lot is affected and what to do.

Is yours affected?

9 products

Match the lot code and NDC listed under your product.

  1. Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 fl oz (15 mL)…

    NDC
    • 42494-448-05
    Lot
    • 3163
    • 3164
  2. Walgreens Lubricant Eye Drops, 0.5 fl oz (15 mL) 1.0 fl oz (30 mL) Total, 2 count Twin Pack

    NDC
    • 0363-8833-15
    Lot
    • 3165
    • 3179
    • 3204
    • 3206
    • 3208
    • 3259
    • 3265
    • 3268
    • 3272
    • 3273
    • 3276
    • 3278
    • 3280
    • 3307
    • 3309
    • 3315
  3. AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 fl oz (15 mL) EACH…

    NDC
    • 50268-068-02
    Lot
    • 3161
    • 3245
    • 3260
    • 3298
    • 3299
    • 3300
    • 3301
    • 3302
    • 3305
    • 3306
  4. Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 fl oz (15 mL) bottles

    NDC
    • 69618-077-55
    Lot
    • 3192
    • 3293
    • 3336
  5. Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes

    NDC
    • 0904-6488-38
    Lot
    • 3183
  6. Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles

    NDC
    • 0363-8833-15
    Lot
    • 3166
    • 3172
    • 3173
    • 3175
    • 3176
    • 3177
    • 3178
    • 3180
    • 3188
    • 3202
    • 3203
    • 3205
    • 3209
    • 3210
    • 3246
    • 3247
    • 3248
    • 3249
    • 3250
    • 3252
    • 3253
    • 3261
    • 3262
    • 3263
    • 3264
    • 3281
  7. AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 fl oz (15 mL) bottle

    NDC
    • 50268-068-15
    Lot
    • 3161
    • 3245
    • 3260
    • 3298
    • 3299
    • 3300
    • 3301
    • 3302
    • 3305
    • 3306
  8. TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL…

    NDC
    • 17312-430-15
    Lot
    • 3279
    • 3292
  9. Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 fl oz (15 mL) bottles

    NDC
    • 69618-076-55
    Lot
    • 3171
    • 3174
    • 3275
    • 3304

Details

Company began the recall
Sold in

USA Nationwide

Event ID
99712
Recall numbers
D-0855-2026 to D-0863-2026
Company
Sterling Pharmaceutical Services LLCDupo, Illinois
Recall type
Voluntary: Firm initiated
Customers told by
Letter
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from Sterling Pharmaceutical Services LLC

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration